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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R.1 492 , S. 832, EPIC Act of 2025, all pharmaceutical related provisions H.R. 7837 Most Favored Patient Act f 2026, all pharmaceutical related provisions H.R. 4299 Protecting Patient Access to Cancer & Complex Therapies Act, all pharmaceutical related provisions H.R. 6609 Pharmacists Fight Back in Medicare and Medicaid Act, all pharmaceutical related provisions P.L. 117-169 Inflation Reduction Act, all pharmaceutical related provisions IRA: Discussions on reform (non-H.R. 4299, e.g., Orphan Cures change, biosimilars, etc) IRA: Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Medicare: Proposals enhance patient access (e.g., protected classes, telehealth, coverage) Medicare: Proposals related to payment proposals (e.g., Part D, Part B, ASP, transparency) Medicaid: Proposals related to access or pricing GLOBE CMMI Model Executive Order
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2026 · third_quarter · Q3
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Source: Senate LDA
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
To amend the Impoundment Control Act of 1974 to require prior approval from Congress before the Comptroller General may pursue a civil action under such Act, and for other purposes.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
To amend the Impoundment Control Act of 1974 to require prior approval from Congress before the Comptroller General may pursue a civil action under such Act, and for other purposes.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
Protecting Patient Access to Cancer and Complex Therapies Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R.1 492 , S. 832, EPIC Act of 2025, all pharmaceutical related provisions H.R. 7837 Most Favored Patient Act f 2026, all pharmaceutical related provisions H.R. 4299 Protecting Patient Access to Cancer & Complex Therapies Act, all pharmaceutical related provisions H.R. 6609 Pharmacists Fight Back in Medicare and Medicaid Act, all pharmaceutical related provisions P.L. 117-169 Inflation Reduction Act, all pharmaceutical related provisions IRA: Discussions on reform (non-H.R. 4299, e.g., Orphan Cures change, biosimilars, etc) IRA: Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Medicare: Proposals enhance patient access (e.g., protected classes, telehealth, coverage) Medicare: Proposals related to payment proposals (e.g., Part D, Part B, ASP, transparency) Medicaid: Proposals related to access or pricing GLOBE CMMI Model Executive Order
340B PATIENTS Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
340B ACCESS Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Pharmacists Fight Back in Medicare and Medicaid Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R.1 492 , S. 832, EPIC Act of 2025, all pharmaceutical related provisions H.R. 7837 Most Favored Patient Act f 2026, all pharmaceutical related provisions H.R. 4299 Protecting Patient Access to Cancer & Complex Therapies Act, all pharmaceutical related provisions H.R. 6609 Pharmacists Fight Back in Medicare and Medicaid Act, all pharmaceutical related provisions P.L. 117-169 Inflation Reduction Act, all pharmaceutical related provisions IRA: Discussions on reform (non-H.R. 4299, e.g., Orphan Cures change, biosimilars, etc) IRA: Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Medicare: Proposals enhance patient access (e.g., protected classes, telehealth, coverage) Medicare: Proposals related to payment proposals (e.g., Part D, Part B, ASP, transparency) Medicaid: Proposals related to access or pricing GLOBE CMMI Model Executive Order
Most Favored Patient Act of 2026
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R.1 492 , S. 832, EPIC Act of 2025, all pharmaceutical related provisions H.R. 7837 Most Favored Patient Act f 2026, all pharmaceutical related provisions H.R. 4299 Protecting Patient Access to Cancer & Complex Therapies Act, all pharmaceutical related provisions H.R. 6609 Pharmacists Fight Back in Medicare and Medicaid Act, all pharmaceutical related provisions P.L. 117-169 Inflation Reduction Act, all pharmaceutical related provisions IRA: Discussions on reform (non-H.R. 4299, e.g., Orphan Cures change, biosimilars, etc) IRA: Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Medicare: Proposals enhance patient access (e.g., protected classes, telehealth, coverage) Medicare: Proposals related to payment proposals (e.g., Part D, Part B, ASP, transparency) Medicaid: Proposals related to access or pricing GLOBE CMMI Model Executive Order
CLEAR LABELS Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
SECURE 340B Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Drug Competition Enhancement Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Stop STALLING Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Preserve Access to Affordable Generics and Biosimilars Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Biosimilar Red Tape Elimination Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
340B PATIENTS Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Medication Affordability and Patent Integrity Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
EPIC Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
EPIC Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
EPIC Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R.1 492 , S. 832, EPIC Act of 2025, all pharmaceutical related provisions H.R. 7837 Most Favored Patient Act f 2026, all pharmaceutical related provisions H.R. 4299 Protecting Patient Access to Cancer & Complex Therapies Act, all pharmaceutical related provisions H.R. 6609 Pharmacists Fight Back in Medicare and Medicaid Act, all pharmaceutical related provisions P.L. 117-169 Inflation Reduction Act, all pharmaceutical related provisions IRA: Discussions on reform (non-H.R. 4299, e.g., Orphan Cures change, biosimilars, etc) IRA: Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Medicare: Proposals enhance patient access (e.g., protected classes, telehealth, coverage) Medicare: Proposals related to payment proposals (e.g., Part D, Part B, ASP, transparency) Medicaid: Proposals related to access or pricing GLOBE CMMI Model Executive Order
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on spillover related to the IRA Discussions on reforming the Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act H.R.1 492, S. 832, EPIC Act of 2025, All Pharmaceutical Related Provisions H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on spillover related to the IRA Discussions on reforming the Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act H.R.1 492, S. 832, EPIC Act of 2025, All Pharmaceutical Related Provisions H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act
PLASMA Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarifying or reforming the 340B program Value-based drug contracting Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Customs Border Protection changes impacting southern border plasma collections Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills H.R. 1476, S. 694, PLASMA Act H.R. 2528, Association Health Plans Act H.R. 2214, DRUG Act
PLASMA Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Issues related to rare disease diagnosis and access to care Issues related to Pharmacy Benefit Managers (PBMs) H.R. 1476, S. 694, PLASMA Act
PLASMA Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Issues related to rare disease diagnosis and access to care Issues related to Pharmacy Benefit Managers (PBMs) H.R. 1476, S. 694, PLASMA Act
DRUG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Value-based drug contracting Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills H.R. 2214, DRUG Act HP. 4299 - Protecting Patient Access to Cancer and Complex Therapies Act
DRUG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarifying or reforming the 340B program Value-based drug contracting Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Customs Border Protection changes impacting southern border plasma collections Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills H.R. 1476, S. 694, PLASMA Act H.R. 2528, Association Health Plans Act H.R. 2214, DRUG Act
DRUG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues H.R. 2214, DRUG Act
Association Health Plans Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarifying or reforming the 340B program Value-based drug contracting Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Customs Border Protection changes impacting southern border plasma collections Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills H.R. 1476, S. 694, PLASMA Act H.R. 2528, Association Health Plans Act H.R. 2214, DRUG Act
To amend the Impoundment Control Act of 1974 to require prior approval from Congress before the Comptroller General may pursue a civil action under such Act, and for other purposes.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
To amend the Impoundment Control Act of 1974 to require prior approval from Congress before the Comptroller General may pursue a civil action under such Act, and for other purposes.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on spillover related to the IRA Discussions on reforming the Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act H.R.1 492, S. 832, EPIC Act of 2025, All Pharmaceutical Related Provisions H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on spillover related to the IRA Discussions on reforming the Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act H.R.1 492, S. 832, EPIC Act of 2025, All Pharmaceutical Related Provisions H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act
PLASMA Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Issues related to rare disease diagnosis and access to care Issues related to Pharmacy Benefit Managers (PBMs) H.R. 1476, S. 694, PLASMA Act
PLASMA Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Issues related to rare disease diagnosis and access to care Issues related to Pharmacy Benefit Managers (PBMs) H.R. 1476, S. 694, PLASMA Act
PLASMA Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarifying or reforming the 340B program Value-based drug contracting Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Customs Border Protection changes impacting southern border plasma collections Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills H.R. 1476, S. 694, PLASMA Act H.R. 2528, Association Health Plans Act H.R. 2214, DRUG Act
EPIC Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on spillover related to the IRA Discussions on reforming the Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act H.R.1 492, S. 832, EPIC Act of 2025, All Pharmaceutical Related Provisions H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act
EPIC Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on spillover related to the IRA Discussions on reforming the Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act H.R.1 492, S. 832, EPIC Act of 2025, All Pharmaceutical Related Provisions H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act
EPIC Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
EPIC Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023 HR10445 Continuing Resolution through 3/17/2025 HR 9747, Continuing Appropriations and Extensions Act, 2025
Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023 HR10445 Continuing Resolution through 3/17/2025 HR 9747, Continuing Appropriations and Extensions Act, 2025
PROTECT 340B Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
PROTECT 340B Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
PROTECT 340B Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
PROTECT 340B Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
PROTECT 340B Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Safe Step Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
National Defense Authorization Act for Fiscal Year 2024
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
National Defense Authorization Act for Fiscal Year 2024
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
National Defense Authorization Act for Fiscal Year 2024
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
National Defense Authorization Act for Fiscal Year 2024
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
American Innovation and R&D Competitiveness Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Tax incentive issues as they relate to proposed global supply chain bills Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits S. 866/H.R. 2673, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization H.R. 3665, To provide an enforcement of remedies against the extraterritorial taxes and discriminatory taxes of foreign countries. General issues around 2025 Reconciliation/Inbound Concerns
American Innovation and R&D Competitiveness Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Tax incentive issues as they relate to proposed global supply chain bills Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits S. 866/H.R. 2673, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization H.R. 3665, To provide an enforcement of remedies against the extraterritorial taxes and discriminatory taxes of foreign countries. General issues around 2025 Reconciliation/Inbound Concerns
American Innovation and R&D Competitiveness Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Tax incentive issues as they relate to proposed global supply chain bills Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits Administration's Global Tax Proposal S. 866/H.R. 2673, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization
American Innovation and R&D Competitiveness Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Tax incentive issues as they relate to proposed global supply chain bills S. 866/H.R. 2673, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization
American Innovation and R&D Competitiveness Act of 2023
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
S. 866/H.R. 2673, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization
Pharmacy Benefits Manager Accountability Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Pharmacy Benefits Manager Accountability Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
Pharmacy Benefit Manager Sunshine and Accountability Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Pharmacy Benefit Manager Sunshine and Accountability Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
Pharmacy Benefit Manager Sunshine and Accountability Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Protecting Patients Against PBM Abuses Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Protecting Patients Against PBM Abuses Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
Protecting Patients Against PBM Abuses Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Further Consolidated Appropriations Act, 2024
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
FY2024, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations H.R. 2882, P.L. 118-47, Further Consolidated Appropriations Act 2024 H.R. 4366, P.L. 118-42 Consolidated Appropriations Act 2024
Defending American Jobs and Investment Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Tax incentive issues as they relate to proposed global supply chain bills Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits S. 866/H.R. 2673, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization H.R. 3665, To provide an enforcement of remedies against the extraterritorial taxes and discriminatory taxes of foreign countries. General issues around 2025 Reconciliation/Inbound Concerns
Defending American Jobs and Investment Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Tax incentive issues as they relate to proposed global supply chain bills Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits S. 866/H.R. 2673, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization H.R. 3665, To provide an enforcement of remedies against the extraterritorial taxes and discriminatory taxes of foreign countries. General issues around 2025 Reconciliation/Inbound Concerns
Consolidated Appropriations Act, 2024
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
FY2024, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations H.R. 2882, P.L. 118-47, Further Consolidated Appropriations Act 2024 H.R. 4366, P.L. 118-42 Consolidated Appropriations Act 2024
Lower Costs, More Transparency Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Lower Costs, More Transparency Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Lower Costs, More Transparency Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Lower Costs, More Transparency Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Lower Costs, More Transparency Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
DRUG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
DRUG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
DRUG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
DRUG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
DRUG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
BIOSECURE Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 7085, BIOSECURE ACT S. 3385, A bill to prohibit contracting with certain biotechnology providers
BIOSECURE Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 7085, BIOSECURE ACT S. 3385, A bill to prohibit contracting with certain biotechnology providers S. 3558, A bill to prohibit contracting with certain biotechnology providers
BIOSECURE Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 7085, BIOSECURE ACT S. 3385, A bill to prohibit contracting with certain biotechnology providers
BIOSECURE Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 7085, BIOSECURE ACT S. 3385, A bill to prohibit contracting with certain biotechnology providers S. 3558, A bill to prohibit contracting with certain biotechnology providers
BIOSECURE Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 7085, BIOSECURE ACT S. 3385, A bill to prohibit contracting with certain biotechnology providers S. 3558, A bill to prohibit contracting with certain biotechnology providers
To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
Discussions around Supply Chain implications
Issues related to proposed Tariffs - all pharmaceutical related provisions
H.R.1 492 , S. 832, EPIC Act of 2025, all pharmaceutical related provisions H.R. 7837 Most Favored Patient Act f 2026, all pharmaceutical related provisions H.R. 4299 Protecting Patient Access to Cancer & Complex Therapies Act, all pharmaceutical related provisions H.R. 6609 Pharmacists Fight Back in Medicare and Medicaid Act, all pharmaceutical related provisions P.L. 117-169 Inflation Reduction Act, all pharmaceutical related provisions IRA: Discussions on reform (non-H.R. 4299, e.g., Orphan Cures change, biosimilars, etc) IRA: Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Medicare: Proposals enhance patient access (e.g., protected classes, telehealth, coverage) Medicare: Proposals related to payment proposals (e.g., Part D, Part B, ASP, transparency) Medicaid: Proposals related to access or pricing GLOBE CMMI Model Executive Order
Administration's Global Tax Proposal Tax incentive issues as they relate to proposed global supply chain bills Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2026 · second_quarter · Q2
Clarify or reform the 340B program Value-based drug contracting Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues SECURE 340B Act (bill# not listed yet) Senate Finance Committee Drug Pricing RFI
Issues related to proposed Tariffs - all pharmaceutical related provisions
Discussions around Supply Chain implications BIOSECURE implementation COINS implementation
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
Filing targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2026 · first_quarter · Q1
Discussions around Supply Chain implications
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues
General intellectual property policy issues Issues related to proposed Tariffs - all pharmaceutical related provisions
Administration's Global Tax Proposal General issues around 2026 Reconciliation/Inbound Concerns
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2025 · fourth_quarter · Q4
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues H.R. 2214, DRUG Act
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits Administration's Global Tax Proposal General issues around 2025 Reconciliation/Inbound Concerns
General intellectual property policy issues Issues related to proposed Tariffs - all pharmaceutical related provisions
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2025 · third_quarter · Q3
FY 2025 Budget Resolution - Pharmaceutical Related Provisions
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
Clarify or reform the 340B program Value-based drug contracting Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills H.R. 2214, DRUG Act HP. 4299 - Protecting Patient Access to Cancer and Complex Therapies Act
Tax incentive issues as they relate to proposed global supply chain bills Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits Administration's Global Tax Proposal General issues around 2025 Reconciliation/Inbound Concerns
Issues related to proposed Tariffs - all pharmaceutical related provisions
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2025 · second_quarter · 2A
FY 2025 Budget Resolution - Pharmaceutical Related Provisions
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on spillover related to the IRA Discussions on reforming the Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act H.R.1 492, S. 832, EPIC Act of 2025, All Pharmaceutical Related Provisions H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act
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2025 · second_quarter · Q2
FY 2025 Budget Resolution - Pharmaceutical Related Provisions
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on spillover related to the IRA Discussions on reforming the Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act Discussions on treatment of small molecule drugs related to Inflation Reduction Act H.R.1 492, S. 832, EPIC Act of 2025, All Pharmaceutical Related Provisions H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act
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2025 · first_quarter · Q1
FY 2025 Budget Resolution - Pharmaceutical Related Provisions
Tax incentive issues as they relate to proposed global supply chain bills Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits Administration's Global Tax Proposal General issues around 2025 Reconciliation/Inbound Concerns
Clarifying or reforming the 340B program Value-based drug contracting Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Customs Border Protection changes impacting southern border plasma collections Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills H.R. 1476, S. 694, PLASMA Act H.R. 2528, Association Health Plans Act H.R. 2214, DRUG Act
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2024 · fourth_quarter · 4A
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Medicare payment proposals Medicare telehealth proposals Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027
H.R. 7085, BIOSECURE ACT S. 3385, A bill to prohibit contracting with certain biotechnology providers
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2024 · fourth_quarter · Q4
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Medicare payment proposals Medicare telehealth proposals Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027
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2024 · third_quarter · Q3
H.R. 7085, BIOSECURE ACT S. 3385, A bill to prohibit contracting with certain biotechnology providers S. 3558, A bill to prohibit contracting with certain biotechnology providers
Tax incentive issues as they relate to proposed global supply chain bills Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits Administration's Global Tax Proposal S. 866/H.R. 2673, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
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2024 · second_quarter · Q2
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare Medicare payment proposals CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 HR 8412 Clinical Trials Modernization Act
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2024 · first_quarter · Q1
FY2024, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations H.R. 2882, P.L. 118-47, Further Consolidated Appropriations Act 2024 H.R. 4366, P.L. 118-42 Consolidated Appropriations Act 2024
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties
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2023 · fourth_quarter · Q4
FY2024, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations H.R. 5860, Making continuing appropriations for fiscal year 2024, and for other purposes
S. 866/H.R. 2673, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Proposals related to amending the protected classes in Medicare CMS Transparency in Coverage Final Rule (CMS-9915-F) CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties
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2023 · third_quarter · Q3
FY2024, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations; P.L. 117-328, Consolidated Appropriations Act, 2023 - provisions related to IVIG Demo, pharmaceutical issues, PDUFA and BsUFA, PIE ACT, accelerated approval pathways, clinical trial design; H.R. 5860, Making continuing appropriations for fiscal year 2024, and for other purposes;
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; Modernizing and Ensuring PBM Accountability (MEPA) Act H.R.410, S.1130, Health Care PRICE Transparency Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act; H.R. 5539, Orphan Cures Act;
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2023 · second_quarter · Q2
FY2024, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations; P.L. 117-328, Consolidated Appropriations Act, 2023 - provisions related to IVIG Demo, pharmaceutical issues, PDUFA and BsUFA, PIE ACT, accelerated approval pathways, clinical trial design; FY2024, Department of Defense Appropriations;
Issues related to trade-related pharmaceutical intellectual property (TRIPS); General intellectual property policy issues;
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; Medicare telehealth proposals; IVIG Medicare demonstration project; P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties; Implementation of 2023 Physician Fee Schedule rule related to Part B discarded drug policy; H.R. 2666, Medicaid VBPs for Patients Act or MVP Act - issues related to value based payment arrangements; E.O. 14087, Lowering Prescription Drug Costs for Americans - issues related to CMMI modeling; CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List
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2023 · first_quarter · Q1
FY2024, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations; P.L. 117-328, Consolidated Appropriations Act, 2023 - provisions related to IVIG Demo, pharmaceutical issues, PDUFA and BsUFA, PIE ACT, accelerated approval pathways, clinical trial design;
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; Medicare telehealth proposals; IVIG Medicare demonstration project; P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties; Implementation 2023 Physician Fee Schedule rule related to Part B discarded drug policy; E.O. 14087, Lowering Prescription Drug Costs for Americans - issues related to CMMI Modeling
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2022 · fourth_quarter · Q4
Issues related to trade-related pharmaceutical intellectual property (TRIPS);
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; H. Res. 1390, Expressing Support for the Six Medicare Protected Class; Medicare payment proposals; Medicare telehealth proposals; IVIG Medicare demonstration project; CMS Medicaid Value Based Purchasing Final Rule (CMS 2482-F); P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties; Implementation 2023 Physician Fee Schedule rule related to Part B discarded drug policy; H.R. 4941, PACE Part D Choice Action of 2021 - provisions related to Medicare PDP;
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2022 · third_quarter · Q3
Issues related to trade-related pharmaceutical intellectual property (TRIPS);
FY2023, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations - issues related to Zika funding; H.R. 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023; H.R. 6833 Continuing Appropriations Act 2023 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA);
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; E.O. 14081 Advancing Biotechnology and Biomanufacturing Innovation;
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2022 · second_quarter · Q2
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 7667, Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; S. 2164, Lower Costs, More Cures Act of 2021; H.R. 6833, Affordable Insulin Now Act; S. 2199, Insulin Price Reduction Act;
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2022 · first_quarter · Q1
Issues related to trade-related pharmaceutical intellectual property (TRIPS);
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; Proposals related to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA) (no bills introduced); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for postapproval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; S. 3339, Capping Prescription Costs Act of 2021; S. 3700, Affordable Insulin Now Act; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives;
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2021 · fourth_quarter · Q4
FY2022, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations- HHS provisions related to prescription drugs; S. Con. Res. 14 -- A bill to provide for reconciliation pursuant to title II of the Concurrent Resolution on the Budget for Fiscal Year 2022 - provisions related to drug pricing;
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; Discussions related to CURES 2.0 potential legislation and provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; P.L. 117-58 (H.R.3684), Infrastructure Investment and Jobs Act - provisions related to vial size; E.O. 13951, An America-First Healthcare Plan;
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2021 · second_quarter · 2A
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor;
Implementation of H.R. 1, Tax Cuts and Jobs Act (P.L. 115-97); Tax incentive issues as they relate to proposed global supply chain bills; Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits; H.R. 1304, American Innovation and R&D Competitiveness Act of 2021 - provisions related to R&D tax issues; S.749, American Innovation and Jobs Act - provisions related to R&D tax issues; Administrations's Global Tax Proposal;
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2021 · first_quarter · 1A
Implementation of H.R. 1, Tax Cuts and Jobs Act (P.L. 115-97); Tax incentive issues as they relate to proposed global supply chain bills; Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits;
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals;
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2021 · third_quarter · Q3
Implementation of H.R. 1, Tax Cuts and Jobs Act (P.L. 115-97); Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits; H.R. 1304, American Innovation and R&D Competitiveness Act of 2021 - provisions related to R&D tax issues; S.749, American Innovation and Jobs Act - provisions related to R&D tax issues; Administration's Global Tax Proposal;
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals;
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2021 · second_quarter · Q2
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor;
Implementation of H.R. 1, Tax Cuts and Jobs Act (P.L. 115-97); Tax incentive issues as they relate to proposed global supply chain bills; Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits; H.R. 1304, American Innovation and R&D Competitiveness Act of 2021 - provisions related to R&D tax issues; S.749, American Innovation and Jobs Act - provisions related to R&D tax issues; Administrations's Global Tax Proposal;
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2021 · first_quarter · Q1
P.L. 116-159, Continuing Appropriations Act, 2021 and Other Extensions Act - provisions related to pedriatics review voucher extention, IVIG Medicare demonstration, general government funding; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - provisions related to home infusion, BEAT tax, drug pricing and patient access; P.L. 116-260, Consolidated Appropriations Act 2021 - provisions related to PRV and IVIG Medicare demonstration program extensions, general government funding. FY2022, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations- HHS provisions related to prescription drugs;
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals;
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2020 · fourth_quarter · 4A
Tax incentive issues as they relate to proposed global supply chain legislation; Discussions related to the repeal of BEAT - provisions related to orphan drug tax credits;
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - provisions related to Medicaid drug rebates; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access;
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2020 · third_quarter · 3A
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs; P.L. 116-159, Continuing Appropriations Act, 2021 and Other Extensions Act - provisions related to pedriatics review voucher extention, IVIG Medicare demonstration, general government funding; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - provisions related to home infusion, BEAT tax, drug pricing and patient access;
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment;
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2020 · fourth_quarter · Q4
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - provisions related to Medicaid drug rebates; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access;
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2020 · third_quarter · Q3
Tax incentive issues as they relate to proposed global supply chain legislation; Discussions related to the repeal of BEAT - provisions related to orphan drug tax credits;
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs; P.L. 116-159, Continuing Appropriations Act, 2021 and Other Extensions Act - provisions related to pedriatics review voucher extention, IVIG Medicare demonstration, general government funding; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - provisions related to home infusion, BEAT tax, drug pricing and patient access;
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2020 · second_quarter · Q2
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign;
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2020 · first_quarter · Q1
Implementation of H.R. 1, Tax Cuts and Jobs Act (P.L. 115-97)
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;
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2019 · third_quarter · 3A
Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 3, Keeping Health Insurance Affordable Act - provisions related to prescription drug pricing; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 340, H.R. 965, The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act - provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems; H.R. 1034, Phair Pricing Act of 2019 - provisions related to Part D and manufacturer rebates; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 2296, S. 1391, FAIR Drug Pricing Act of 2019 - provisions related to prescription drug pricing and transparency; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; Proposed FDA guidance on gastroparesis clinical trials; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after discharge from active duty;
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2019 · fourth_quarter · Q4
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; S. 475, The Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act - provisions related to Part D and patient cost-sharing; S. 476, The Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act - provisions related to transparency of prescription drug pricing and pharmacy benefit managers; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - provisions related to Medicaid drug rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; Policies that could be applied relative to transparency of drug pricing; H.R. 3 Lower Drug Costs Now Act 2019
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2019 · third_quarter · Q3
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs; FY2020, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations- HHS provisions related to prescription drugs;
Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 3, Keeping Health Insurance Affordable Act - provisions related to prescription drug pricing; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 340, H.R. 965, The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act - provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems; H.R. 1034, Phair Pricing Act of 2019 - provisions related to Part D and manufacturer rebates; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 2296, S. 1391, FAIR Drug Pricing Act of 2019 - provisions related to prescription drug pricing and transparency; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; Proposed FDA guidance on gastroparesis clinical trials; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after discharge from active duty;
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2019 · second_quarter · Q2
H.R. 1, For the People Act of 2019 - provisions related to amending the Foreign Agent Registration Act; S.1762, Foreign Agents Disclosure and Registration Enhancement Act of 2019 - provisions related to amending the Foreign Agent Registration Act;
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs; FY2020, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations- HHS provisions related to prescription drugs;
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2019 · first_quarter · Q1
Implementation of H.R. 1, Tax Cuts and Jobs Act (P.L. 115-97);
Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D; Proposals related to protected classes; Medicare payment proposals; CMS guidance to Medicare Advantage Plans allowing the use of step-therapy; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act;
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2018 · fourth_quarter · Q4
Discussions related to the implementation of H.R. 1, Tax Cuts and Jobs Act (P.L. 115-97);
Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D; Proposals related to protected classes; Medicare payment proposals; H.R. 7217, IMPROVE Act; CMS guidance to Medicare Advantage Plans allowing the use of step-therapy; H.R. 6642, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs; CMS guidance on 1332 waivers [CMS-9936-NC];
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2018 · third_quarter · Q3
Discussions related to the implementation of H.R. 1, Tax Cuts and Jobs Act (P.L. 115-97);
S. 2852, H.R. 6378, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018; H.R. 4710, 340B PAUSE Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; H.R. 2077, Restoring the Patient's Voice Act of 2017; S. 1348, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017; Proposals related to drug pricing; H.R.2026, Pharmaceutical Information Exchange Act; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute;
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2018 · second_quarter · Q2
Implementation of H.R. 1, Tax Cuts and Jobs Act (P.L. 115-97); Tax Reform Technical Corrections;
Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D; Proposals related to protected classes; Medicare payment proposals;
S. 2039, H.R. 4170, Disclosing Foreign Influence Act; S. 2482, Foreign Agents Registration Amendments Act of 2018;
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2018 · first_quarter · Q1
S. 2039, H.R. 4170, Disclosing Foreign Influence Act; S. 2482, Foreign Agents Registration Amendments Act of 2018;
Proposals for the Pandemic All Hazards Prepardness Act, specifically the provisions related to the Biomedical Advanced Research and Development Authority reauthorization; S. 934, H.R. 2430, FDA Reauthorization Act of 2017 (P.L. 115-52); H.R. 4710, 340B PAUSE Act; S. 2312, HELP Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; S. 204, H.R. 878, Trickett Wendler Right to Try Act of 2017; H.R. 5247, Trickett Wendler Right to Try Act of 2018; H.R. 2077, Restoring the Patient's Voice Act of 2017; H.R. 1409, Cancer Drug Parity Act; S. 469, H.R. 1245, Affordable and Safe Prescription Drug Importation Act; S. 771, H.R. 1776, Improving Access To Affordable Prescription Drugs Act; H.R. 1316, Prescription Drug Price Transparency Act; S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; Proposals related to drug pricing; H.R.2026, Pharmaceutical Information Exchange Act; H.R. 3921, HEALTHY KIDS Act; S. 1827, KIDS Act of 2017; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute; H.R. 749, Lower Costs Through Competition Act;
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2017 · fourth_quarter · Q4
Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Proposals related to protected classes; Discussions related to rebates and Medicare part D; Medicare payment proposals;
S. Con. Res. 3, A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026; S. 1519, H.R. 2810, National Defense Authorization Act for Fiscal Year 2018; H.R.244, Consolidated Appropriations Act 2017 (P.L.115-31); FY2018, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations;
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2017 · third_quarter · Q3
Senate and House Committee Tax Reform Proposals;
Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Proposals related to protected classes; Discussions related to rebates and Medicare part D; Medicare payment proposals;
P.L. 111-148, Patient Protection and Affordable Care Act; Repeal and Replace Proposals for Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 1628, American Health Care Act of 2017; S. 934, H.R. 2430, FDA Reauthorization Act of 2017; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; S. 204, H.R. 878, Trickett Wendler Right to Try Act of 2017; H.R. 2077, Restoring the Patient's Voice Act of 2017; S. 469, H.R. 1245, Affordable and Safe Prescription Drug Importation Act; S. 348, Prescription Drug and Health Improvement Act of 2017; S. 771, H.R. 1776, Improving Access To Affordable Prescription Drugs Act; H.R. 1316, Prescription Drug Price Transparency Act; S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; S. 1348, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017; S. 1369, H.R. 2974, Stop Price Gouging Act of 2017; S. 892, Opioid Addiction Prevention Act of 2017; S. 1681, A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services; H.R. 849, the Protecting Seniors Access to Medicare Act; Proposals related to drug pricing; Implementation of P.L.114-255, 21st Century Cures Act; Issues related to depression and mental health;
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2017 · second_quarter · Q2
Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Proposals related to protected classes; Discussions related to rebates and Medicare part D; Medicare payment proposals; Discussions related to the activities of the Independent Payment Advisory Board (IPAB);
H.R. 2810, National Defense Authorization Act for Fiscal Year 2018; FY2018, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations; FY2018, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations; H.R.244, Consolidated Appropriations Act 2017 (P.L.115-31);
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2017 · first_quarter · Q1
P.L. 111-148, Patient Protection and Affordable Care Act; Repeal and Replace Proposals for Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 1628, American Health Care Act of 2017; Implementation/Reauthorization of The Prescription Drug User Fee Act (PDUFA); Discussions to clarify or reform the 340B program; S. 469, H.R. 1245, Affordable and Safe Prescription Drug Importation Act; S. 204, Trickett Wendler Right to Try Act of 2017; S. 348, Prescription Drug and Health Improvement Act of 2017; S. 771, H.R. 1776, Improving Access To Affordable Prescription Drugs Act; H.R. 1316, Prescription Drug Price Transparency Act; S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 (not yet introduced); Proposals related to drug pricing;
Senate and House Committee Tax Reform Proposals;
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2016 · fourth_quarter · Q4
H.R. 6: 21st Century Cures/Innovation Act
Part D Protected classes provision of Affordable Care Act (S648); CMS Part B Demo; Notice of Benefit and Payment Parameters for 2018
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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2016 · third_quarter · Q3
H.R. 6: 21st Century Cures/Innovation Act
Medicare Part D-activities related to HR 2404/S 1509 (The Treat and Reduce Obesity Act of 2013); Part D Protected classes provision of Affordable Care Act (S648); CMS Part B Demo
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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2016 · second_quarter · Q2
Moonshoot Initiative
Vial Size/Appropriations
Medicare Part D-activities related to HR 2404/S 1509 (The Treat and Reduce Obesity Act of 2013); Part D Protected classes provision of Affordable Care Act (S648); CMMI Proposed Part B Payment Model
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2016 · first_quarter · 1A
H.R. 6: 21st Century Cures/Innovation Act
Zika Virus; Moonshoot Initiative
Medicare Part D-activities related to HR 2404/S 1509 (The Treat and Reduce Obesity Act of 2013); Part D Protected classes provision of Affordable Care Act (S648); H.R. 3204: The Drug Quality and Security Act; CMMI Proposed Part B Payment Model; CMS Part B Demo
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2016 · first_quarter · Q1
H.R. 6: 21st Century Cures/Innovation Act
Zika Virus; Moonshoot Initiative
Medicare Part D-activities related to HR 2404/S 1509 (The Treat and Reduce Obesity Act of 2013); Part D Protected classes provision of Affordable Care Act (S648); H.R. 3204: The Drug Quality and Security Act; CMMI Proposed Part B Payment Model; CMS Part B Demo
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2015 · fourth_quarter · Q4
H.R. 6: 21st Century Cures
Medicare Part D-activities related to HR 2404/S 1509 (The Treat and Reduce Obesity Act of 2013); Part D Protected classes provision of Affordable Care Act (S648); Alzheimer's disease Part D coverage
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2015 · third_quarter · 3A
Medicare Part D-activities related to HR 2404/S 1509 (The Treat and Reduce Obesity Act of 2013); Part D Protected classes provision of Affordable Care Act (S648); Alzheimer's disease Part D coverage
H.R. 9
H.R. 6: 21st Century Cures
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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2015 · third_quarter · Q3
H.R. 9
H.R. 6: 21st Century Cures
Medicare Part D-activities related to HR 2404/S 1509 (The Treat and Reduce Obesity Act of 2013); Part D Protected classes provision of Affordable Care Act (S648); Alzheimer's disease Part D coverage
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2015 · second_quarter · Q2
Medicare Part D-activities related to HR 2404/S 1509 (The Treat and Reduce Obesity Act of 2013); Part D Protected classesprovision of Affordable Care Act (S648); TOMM-40 (HR 6); Alzheimer's disease Part D coverage
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2015 · first_quarter · Q1
Medicare Part D-activities related to HR 2415/S 1184 (The Treat and Reduce Obesity Act of 2013); Part D Protected classes provision of Affordable Care Act; Part D forumulary requirements-manual; Alzheimer's disease Part D coverage; CMS letter re: quarterly NOC update
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2014 · fourth_quarter · Q4
Medicare Part D-activities related to HR 2415/S 1184 (The Treat and Reduce Obesity Act of 2013); Part D Protected classes provision of Affordable Care Act; Medicaid entitlement reform and codifying protected classes
Pilot Project on Rapid Response Determination
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2014 · third_quarter · 3A
Medicare Part D-activities related to HR 2415/S 1184 (The Treat and Reduce Obesity Act of 2013); Part D Protected classes provision of Affordable Care Act; Sec. 3307 of the Affordable Care Act. Improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; Medicaid entitlement reform and codifying protected classes
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2014 · third_quarter · Q3
Medicare Part D-activities related to HR 2415/S 1184 (The Treat and Reduce Obesity Act of 2013); Part D Protected classes provision of Affordable Care Act; Sec. 3307 of the Affordable Care Act. Improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; Medicaid entitlement reform and codifying protected classes
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2014 · second_quarter · 2A
Medicare Part D-activities related to HR 2415/S 1184 (The Treat and Reduce Obesity Act of 2013); Protected classes provision of Affordable Care Act; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs; Proposed Rule; Medicaid entitlement reform
Orphan drug ACA fee exemption
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2014 · first_quarter · Q1
Medicare Part Dactivities related to HR 2415/S 1184 (The Treat and Reduce Obesity Act of 2013); CMS proposed rule on protected classes; H.R. 4160, the Keep the Promise to Seniors Act; Helping Families In Mental Health Crisis Act (Murphy bill); Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs Proposed Rule
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2013 · fourth_quarter · Q4
HR 3717 ("The Helping Families in Mental Health Crisis Act of 2013")
R&D tax credit-promote extension and/or permanence
Medicare Part D-research and preparation on depression drug coverage under Part D; HR 2415/S 1184-The Treat and Reduce Obesity Act of 2013
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2013 · third_quarter · Q3
S 959-The Pharmaceutical Compounding Quality and Accountability Act; HR 1919-The Safeguarding America's Pharmaceuticals Act of 2013
R&D tax credit-promote extension and/or permanence
Medicare Part D-research and preparation on depression drug coverage under Part D; HR 2415/S 1184-The Treat and Reduce Obesity Act of 2013
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2013 · second_quarter · Q2
R&D tax credit-promote extension and/or permanence
Counterfeit drugs, serialization and development of tracibility model
Medicare coverage of obesity medication
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2013 · first_quarter · Q1
Medicare coverage of obesity medication; Medicare Part D-research, preparation on depression drug coverage, and intial congressional contacts on lack of obesity coverage under Part D; Part B payments for ESRD drugs
Norovirus vaccine development support
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2012 · fourth_quarter · Q4
Counterfeit drugs, serialization and development of tracibility model
Coding and coverage of ESA Drugs; Medicare reform
Implications of deficit reduction
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Issues related to rare disease diagnosis and access to care Issues related to Pharmacy Benefit Managers (PBMs) H.R. 1476, S. 694, PLASMA Act
Administration's Global Tax Proposal General issues around 2025 Reconciliation/Inbound Concerns
Issues related to proposed Tariffs - all pharmaceutical related provisions
Discussions around Supply Chain implications
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Issues related to rare disease diagnosis and access to care Issues related to Pharmacy Benefit Managers (PBMs) H.R. 1476, S. 694, PLASMA Act
Administration's Global Tax Proposal General issues around 2025 Reconciliation/Inbound Concerns
Issues related to proposed Tariffs - all pharmaceutical related provisions
Discussions around Supply Chain implications
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Tax incentive issues as they relate to proposed global supply chain bills Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits S. 866/H.R. 2673, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization H.R. 3665, To provide an enforcement of remedies against the extraterritorial taxes and discriminatory taxes of foreign countries. General issues around 2025 Reconciliation/Inbound Concerns
H.R. 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023 HR10445 Continuing Resolution through 3/17/2025 HR 9747, Continuing Appropriations and Extensions Act, 2025
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
H.R. 7085, BIOSECURE ACT S. 3385, A bill to prohibit contracting with certain biotechnology providers
H.R. 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023 HR10445 Continuing Resolution through 3/17/2025 HR 9747, Continuing Appropriations and Extensions Act, 2025
Tax incentive issues as they relate to proposed global supply chain bills Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits S. 866/H.R. 2673, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization H.R. 3665, To provide an enforcement of remedies against the extraterritorial taxes and discriminatory taxes of foreign countries. General issues around 2025 Reconciliation/Inbound Concerns
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare telehealth proposals CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027
Filing targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE
Issues related to trade-related pharmaceutical intellectual property (TRIPS) General intellectual property policy issues
H.R. 7085, BIOSECURE ACT S. 3385, A bill to prohibit contracting with certain biotechnology providers S. 3558, A bill to prohibit contracting with certain biotechnology providers
Tax incentive issues as they relate to proposed global supply chain bills S. 866/H.R. 2673, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization
Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 830, S.1375, HELP Co-Pays Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to transparency and data disclosure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Ac H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act
S. 866/H.R. 2673, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization
H.R. 7085, BIOSECURE ACT S. 3385, A bill to prohibit contracting with certain biotechnology providers S. 3558, A bill to prohibit contracting with certain biotechnology providers
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 S. 2333, Pandemic and All-Hazards Preparedness and Response Act H.R. 410, S.1130, Health Care PRICE Transparency Act H.R. 830, S.1375, HELP Co-Pays Act H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023 H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5391, S. 2764, Protecting Patient Access to Cancer and Complex Therapies Act (IRA commercial spillover) H.R. 5539, Orphan Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 P.L. 111-148, Patient Protection and Affordable Care Act H.R. 5378 -The Lower Costs, More Transparency Act S. 2973 -Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines HR 6283 Delinking Revenue from Unfair Gouging "DRUG Act" E.O. 14017, America's Supply Chains E.O. 14087, Lowering Prescription Drug Costs for Americans - issues related to CMMI modeling R.F.I. Docket Number 230831-0207, Document Number 2023-26930, Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights
Issues related to trade-related pharmaceutical intellectual property (TRIPS) General intellectual property policy issues
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
S. 866/H.R. 2673, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization; H.R. 3665, To provide an enforcement of remedies against the extraterritorial taxes and discriminatory taxes of foreign countries.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; Medicare telehealth proposals; IVIG Medicare demonstration project; CMS Transparency in Coverage Final Rule (CMS-9915-F); P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to prescription drug prices, implementation, negotiation, Part D redesign, inflation penalties; Implementation of 2023 Physician Fee Schedule rule related to Part B discarded drug policy; CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey; Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List; Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026; Request for Regulatory Clarification with Medicare Administrative Contractor (CMS); Discussions on biosimilars related to IRA; Discussions on spillover related to the IRA; Request for Regulatory Clarification with Medicare Part B Group (CMS);
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
Issues related to patient access of plasma therapies; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022; H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs; H.R.1613, S.1038, Drug Price Transparency in Medicaid Act of 2023; S.1339, Pharmacy Benefit Manager Reform Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; HR 2816, The PBM Sunshine and Accountability Act; S. 1217, Ending the Prescription Drug Kickback Act of 2023; H.R. 2534, PROTECT 340B Act of 2023; S.1131, Drug Price Transparency Act of 2023; S. 127, Pharmacy Benefit Manager Transparency Act; S.113, Prescription Pricing for the People Act; H.R. 830, S.1375, HELP Co-Pays Act; Issues/Discussions related to Senate Finance Committee PBM Framework Paper; Issues/Discussions related to Pharmacy Benefit Managers (PBMs); Discussions on Customs Border Protection changes impacting southern border plasma collections; Promoting the Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Discussions related to rare disease diagnosis and access to care; H.R. 2670, S. 2226, National Defense Authorization Act; S. 2333 Pandemic and All-Hazards Preparedness and Response Act (pre-introduction);
Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits; Administration's Global Tax Proposal; S. 866/H.R. 2673, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization; H.R. 3665, To provide an enforcement of remedies against the extraterritorial taxes and discriminatory taxes of foreign countries.
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; S. 652, Safe Step Act - provisions related to step therapy policy; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; Issues related to Dengue vaccines; Awareness of Rare Disease issues related to diagnosis and care access S. 4293, Pharmacy Benefit Manager Transparency Act of 2022
S. 866, A bill to amend the Internal Revenue Code of 1986 to enhance tax benefits for research activities - issues related to R&D amortization;
Issues related to trade-related pharmaceutical intellectual property (TRIPS); Intellectual property policy issues
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;
Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits; H.R. 1304, American Innovation and R&D Competitiveness Act of 2021 - provisions related to R&D tax issues; S.749, American Innovation and Jobs Act - provisions related to R&D tax issues; P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to tax issues;
FY2023, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations - issues related to Zika funding; H.R. 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023; H.R. 6833 Continuing Appropriations Act 2023 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); P.L. 117-328 (H.R. 2617), Consolidated Appropriations Act, 2023 - provisions related to IVIG Demo, pharmaceutical issues, PDUFA and BsUFA, PIE ACT, accelerated approval pathways, clinical trial design;
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, White House Office
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; H. Res. 1390 Expressing Support for the Six Medicare Protected Class; Medicare payment proposals; Medicare telehealth proposals; CMS Transparency in Coverage Final Rule (CMS-9915-F); CMS Medicaid Value Based Purchasing Final Rule (CMS 2482-F); P.L. 117-169 Inflaction Reduction Act - reconciliation package with provisions related to prescription drug prices and implementation issues; H.R. 7389 MVP Act; Implementation 2023 Physician Fee Schedule rule related to Part B discarded drug policy;
Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits; H.R. 1304, American Innovation and R&D Competitiveness Act of 2021 - provisions related to R&D tax issues; S.749, American Innovation and Jobs Act - provisions related to R&D tax issues; Administration's Global Tax Proposal; P.L. 117-169 Inflation Reduction Act - reconciliation package with provisions related to tax issues;
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
P.L. 116-260, Consolidated Appropriations Act 2021 - provisions related to PRV and IVIG Medicare demonstration program extensions, drug pricing transparency, general government funding. FY2023, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations H.R. 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023;
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; Medicare telehealth proposals; IVIG Medicare demonstration project; CMS Transparency in Coverage Final Rule (CMS-9915-F); CMS Medicaid Value Based Purchasing Final Rule (CMS 2482-F);
Issues related to trade-related pharmaceutical intellectual property (TRIPS);
Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits; H.R. 1304, American Innovation and R&D Competitiveness Act of 2021 - provisions related to R&D tax issues; S.749, American Innovation and Jobs Act - provisions related to R&D tax issues; Administration's Global Tax Proposal; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to tax issues;
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; Policies related to Medicare accumulators; IVIG Medicare demonstration project; CMS Transparency in Coverage Final Rule (CMS-9915-F); CMS Medicaid Value Based Purchasing Final Rule (CMS 2482-F);
Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits; H.R. 1304, American Innovation and R&D Competitiveness Act of 2021 - provisions related to R&D tax issues; Administration's Global Tax Proposal; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to tax issues;
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits; H.R. 1304, American Innovation and R&D Competitiveness Act of 2021 - provisions related to R&D tax issues; S.749, American Innovation and Jobs Act - provisions related to R&D tax issues; Administration's Global Tax Proposal; H.R. 5376, Build Back Better Act (reconciliation package) - provisions related to tax issues;
Issues related to pharmaceutical intellectual property;
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; Policies related to Medicare accumulators; IVIG Medicare demonstration project; CMS Transparency in Coverage Final Rule;
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
P.L. 116-159, Continuing Appropriations Act, 2021 and Other Extensions Act - provisions related to pedriatics review voucher extention, IVIG Medicare demonstration, general government funding; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - provisions related to home infusion, BEAT tax, drug pricing and patient access; P.L. 116-260, Consolidated Appropriations Act 2021 - provisions related to PRV and IVIG Medicare demonstration program extensions, general government funding. FY2022, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations- HHS provisions related to prescription drugs;
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; P.L. 111-148, Patient Protection and Affordable Care Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; Discussions related to CURES 2.0 potential legislation and provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R.1319, P.L. 117-2, American Rescue Plan Act of 2021 - provisions related to COVID-19 vaccinations, testing, treatment, Medicaid rebates, and prevention and mental health services; H.R. 2017, S. 883, To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - provisions related to Part D and drug pricing negotiation; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 464, Safe Step Act - provisions related to step therapy policy (House companion bill not yet introduced); S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act (116th Congress) - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 (116th Congress) - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 19, Lower Costs, More Cures Act of 2019 (116th Congress) - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening;
Issues related to pharmaceutical intellectual property;
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; H.R.1319, P.L. 117-2, American Rescue Plan Act of 2021 - provisions related to COVID-19 vaccinations, testing, treatment, Medicaid rebates, and prevention and mental health services; H.R. 2017, S. 883, To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - provisions related to Part D and drug pricing negotiation; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 464, Safe Step Act - provisions related to step therapy policy (House companion bill not yet introduced); H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act (116th Congress) - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 (116th Congress) - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 19, Lower Costs, More Cures Act of 2019 (116th Congress) - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States;
P.L. 116-159, Continuing Appropriations Act, 2021 and Other Extensions Act - provisions related to pedriatics review voucher extention, IVIG Medicare demonstration, general government funding; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - provisions related to home infusion, BEAT tax, drug pricing and patient access; P.L. 116-260, Consolidated Appropriations Act 2021 - provisions related to PRV and IVIG Medicare demonstration program extensions, general government funding. FY2022, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations- HHS provisions related to prescription drugs;
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; Patient Affordability Value and Efficiency Act (Not Yet Introduced) - to amend titles XI, XVIII, and XIX of the Social Security Act to promote value-based arrangements; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2017, S. 883, To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - provisions related to Part D and drug pricing negotiation; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 (116th Congress) - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5376, Build Back Better Act (and reconciliation package) - provisions related to prescription drug prices; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O. 13950, Combating Race and Sex Stereotyping;
P.L. 116-159, Continuing Appropriations Act, 2021 and Other Extensions Act - provisions related to pedriatics review voucher extention, IVIG Medicare demonstration, general government funding; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - provisions related to home infusion, BEAT tax, drug pricing and patient access; P.L. 116-260, Consolidated Appropriations Act 2021 - provisions related to PRV and IVIG Medicare demonstration program extensions, drug pricing transparency, general government funding. FY2022, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations- HHS provisions related to prescription drugs; S. Con. Res. 14 -- A bill to provide for reconciliation pursuant to title II of the Concurrent Resolution on the Budget for Fiscal Year 2022 - provisions related to drug pricing;
Issues related to pharmaceutical intellectual property;
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
P.L. 116-159, Continuing Appropriations Act, 2021 and Other Extensions Act - provisions related to pedriatics review voucher extention, IVIG Medicare demonstration, general government funding; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - provisions related to home infusion, BEAT tax, drug pricing and patient access; P.L. 116-260, Consolidated Appropriations Act 2021 - provisions related to PRV and IVIG Medicare demonstration program extensions, general government funding. FY2022, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations- HHS provisions related to prescription drugs;
Issues related to pharmaceutical intellectual property;
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; P.L. 111-148, Patient Protection and Affordable Care Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; Discussions related to CURES 2.0 potential legislation and provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R.1319, P.L. 117-2, American Rescue Plan Act of 2021 - provisions related to COVID-19 vaccinations, testing, treatment, Medicaid rebates, and prevention and mental health services; H.R. 2017, S. 883, To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - provisions related to Part D and drug pricing negotiation; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 464, Safe Step Act - provisions related to step therapy policy (House companion bill not yet introduced); S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act (116th Congress) - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 (116th Congress) - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 19, Lower Costs, More Cures Act of 2019 (116th Congress) - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening;
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; H.R.1319, P.L. 117-2, American Rescue Plan Act of 2021 - provisions related to COVID-19 vaccinations, testing, treatment, Medicaid rebates, and prevention and mental health services; H.R. 2017, S. 883, To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - provisions related to Part D and drug pricing negotiation; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 464, Safe Step Act - provisions related to step therapy policy (House companion bill not yet introduced); H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act (116th Congress) - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 (116th Congress) - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 19, Lower Costs, More Cures Act of 2019 (116th Congress) - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States;
Implementation of H.R. 1, Tax Cuts and Jobs Act (P.L. 115-97); Tax incentive issues as they relate to proposed global supply chain bills; Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits;
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; The Patient Affordability, Value and Efficiency Act (not yet introduced); Discussions related to co-pay accumulators; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs; P.L. 116-159, Continuing Appropriations Act, 2021 and Other Extensions Act - provisions related to pedriatics review voucher extention, IVIG Medicare demonstration, general government funding; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - provisions related to home infusion, BEAT tax, drug pricing and patient access; P.L. 116-260, Consolidated Appropriations Act 2021 - provisions related to PRV and IVIG Medicare demonstration program extensions, general government funding.
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Tax incentive issues as they relate to proposed global supply chain legislation; Discussions related to the repeal of BEAT - provisions related to orphan drug tax credits;
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
Tax incentive issues as they relate to proposed global supply chain legislation; Discussions related to the repeal of BEAT - provisions related to orphan drug tax credits;
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs; P.L. 116-159, Continuing Appropriations Act, 2021 and Other Extensions Act - provisions related to pedriatics review voucher extention, IVIG Medicare demonstration, general government funding; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - provisions related to home infusion, BEAT tax, drug pricing and patient access; P.L. 116-260, Consolidated Appropriations Act 2021 - provisions related to PRV and IVIG Medicare demonstration program extensions, general government funding.
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; The Patient Affordability, Value and Efficiency Act (not yet introduced); Discussions related to co-pay accumulators; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign; H.R. 7839, Continuing Access to In-Home IVIG Act - provisions related to patient access; H.R.7783, S.4179, Plasma Donation Awareness Act - provisions related to plasma donation access; H.R. 6218, S. 3457, Preserving Patient Access to Home Infusion Act - provisions related to home infusion payment;
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
Implementation of H.R. 1, Tax Cuts and Jobs Act (P.L. 115-97); Tax incentive issues as they relate to proposed global supply chain bills;
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs; P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act - provisions related to home infusion, BEAT tax, drug pricing and patient access;
Filing targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs;
PL 115-232: Foreign Investment Risk Review Modernization Act of 2018 - provisions related to CFIUS;
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - provisions related to Medicaid drug rebates; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 4649 Capping Drug Costs for Seniors Act - provisions related to Part D redesign;
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 475, The Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act - provisions related to Part D and patient cost-sharing; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - provisions related to Medicaid drug rebates; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 691, Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - provisions related to Part D and patient out-of-pocket costs; S. 801, H.R. 1781, Payment Commission Data Act of 2019 - provisions related to prescription drug pricing transparency and reporting; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions;
H.R. 2740, Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs; FY2020, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations- HHS provisions related to prescription drugs;
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
HR 5430 - United States-Mexico-Canada Agreement Implementation Act
HR 19 - Lower Costs, More Cures Act of 2019
Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue;
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Veterans Affairs, Dept of (VA)
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 475, The Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act - provisions related to Part D and patient cost-sharing; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - provisions related to Medicaid drug rebates; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates; S. 691, Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - provisions related to Part D and patient out-of-pocket costs; S. 801, H.R. 1781, Payment Commission Data Act of 2019 - provisions related to prescription drug pricing transparency and reporting; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions;
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
P.L. 111-148, Patient Protection and Affordable Care Act - provisions related to PCORI reauthorization; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; H.R. 938, The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (the BLOCKING Act) - provisions related to 180 day generic prescription drug exclusivity; H.R. 1188, S. 366, FLAT Prices Act - provisions related to prescription drug exclusivity periods and pricing; S. 340, H.R. 965, The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act - provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems; H.R. 1034, Phair Pricing Act of 2019 - provisions related to Part D and manufacturer rebates; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 73, End Taxpayer Subsidies for Drug Ads Act - provisions related to direct-to-consumer prescription drug advertising; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, Safe Step Act - provisions related to step therapy policy; Patient Affordability Value and Efficiency Act (Not Yet Introduced) - to amend titles XI, XVIII, and XIX of the Social Security Act to promote value-based arrangements; S. 2004, Emergency Access to Insulin Act of 2019 - provisions related to biologics exclusivity; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; S. 659, Biologic Patent Transparency Act - provisions related to prescription drug patent disclosures; H.R. 2069, S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 - provisions related to increases in the wholesale acquisition costs of prescription drugs; S. 977, Transparent Drug Pricing Act of 2019 - provisions related to transparency and drug pricing; S.1140, Protecting Access to Biosimilars Act of 2019 - provisions related to biological products; H.R. 2296, S. 1391, FAIR Drug Pricing Act of 2019 - provisions related to prescription drug pricing and transparency; H.R. 2455, S. 1169, Ensuring Timely Access to Generics Act of 2019 - provisions related to citizen petitions; S. 1416, Affordable Prescriptions for Patients Act of 2019 - provisions related to prescription drug patents; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; Bayh-Dole march-in rights policy issues; S. 3, Keeping Health Insurance Affordable Act - provisions related to prescription drug pricing;
Policies to enhance patient access to medicines in Medicaid including rebate and waiver policy issues; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor; Proposals related to amending the protected classes in Medicare; Medicare payment proposals; S. 62, The Empowering Medicare Seniors to Negotiate Drug Prices Act - provisions related to Part D and drug pricing negotiation; S. 99, H.R. 448, The Medicare Drug Price Negotiation Act - provisions related to Part D and drug pricing negotiation; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 - provisions related to Part D and drug pricing negotiation; S. 476, The Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act - provisions related to transparency of prescription drug pricing and pharmacy benefit managers; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - provisions related to Medicaid drug rebates; S. 377, H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 - provisions related to Part D, drug pricing negotiation and compulsory licensing; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act - provisions related to prescription drug vial sizes and rebates;
Implementation of H.R. 1, Tax Cuts and Jobs Act (P.L. 115-97);
Filing targets: HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of
Proposals for the Pandemic and All-Hazards Preparedness, specifically the provisions related to the Biomedical Advanced Research and Development Authority reauthorization; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing; S. 64, The Preserve Access to Affordable Generics and Biosimilars Act; S. 102, H.R. 465, The Prescription Drug Price Relief Act of 2019; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act; S. 205, The Right Rebate Act of 2019; S. 366, H.R. 1188, FLAT Prices Act; S. 340, H.R. 965, The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act; H.R. 1034, The Phair Price Act; H.R. 1035, The Prescription Drug Price Transparency Act; S. 474, The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act; H.R. 985, The Fair Access for Safe and Timely (FAST) Generics Act of 2019; S. 658, A bill to provide for an accelerated approval pathway for certain drugs that are authorized to be lawfully marketed in other countries; H.R. 1499, To prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes; H.R. 1506, Fair and Immediate Release (FAIR) of Generic Drugs Act; H.R. 1520, Purple Book Continuity Act of 2019; H.R. 1503, Orange Book Transparency Act of 2019; Short on Competition Act (not yet introduced); S. 659, Biologic Patent Transparency Act; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute;
FY2020, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations;
H.R. 1, For the People Act of 2019, specifically proposals related to amending the Foreign Agent Registration Act;
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of
S. 2039, H.R. 4170, Disclosing Foreign Influence Act; S. 2482, Foreign Agents Registration Amendments Act of 2018;
S. Con. Res. 3, A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026; H.R. 1892, Bipartisan Budget Act of 2018; H.R.1625, Consolidated Appropriations Act, 2018 (P.L. 115-141);
S. 2852, H.R. 6378, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, specifically the provisions related to the Biomedical Advanced Research and Development Authority reauthorization; P.L. 111-148, Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; H.R. 2077, Restoring the Patient's Voice Act of 2017;
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
S. 2039, H.R. 4170, Disclosing Foreign Influence Act; S. 2482, Foreign Agents Registration Amendments Act of 2018;
S. Con. Res. 3, A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026; S. 1519, H.R. 2810, National Defense Authorization Act for Fiscal Year 2018; H.R. 1892, Bipartisan Budget Act of 2018; H.R.1625, Consolidated Appropriations Act, 2018 (P.L. 115-141); FY2019, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations;
Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D; Proposals related to protected classes; Discussions related to CMS guidance to Medicare Advantage Plans on step-therapy;
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
S. Con. Res. 3, A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026; S. 1519, H.R. 2810, National Defense Authorization Act for Fiscal Year 2018; H.R. 1892, Bipartisan Budget Act of 2018; FY2019, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations;
S. 2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018; H.R. 4710, 340B PAUSE Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; S. 204, H.R. 878, Trickett Wendler Right to Try Act of 2017; H.R. 5247, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018; H.R. 2077, Restoring the Patient's Voice Act of 2017; H.R. 1409, Cancer Drug Parity Act; S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; S. 1681, A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services; Proposals related to drug pricing; S. 1347, RxCAP Act of 2017; 42 USC 1320a-7b, Anti-Kickback Statute; H.R. 5867, H.R. 6142, Reducing Drug Waste Act of 2018; Discussions related to mental health/depression in the opioid epidemic;
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Policies to enhance patient access to medicines in Medicaid; Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Discussions related to rebates and Medicare part D; Proposals related to protected classes; Medicare payment proposals; S. 260, H.R. 849, the Protecting Seniors Access to Medicare Act;
S. Con. Res. 3, A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026; H.R. 1892, Bipartisan Budget Act of 2018; H.R.1625, Consolidated Appropriations Act, 2018 (P.L. 115-141); H.R. 3268, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2018; FY2018, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations;
Implementation of H.R. 1, Tax Cuts and Jobs Act (P.L. 115-97); Base Erosion Anti-Abuse Tax (BEAT);
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE
H.R. 1, Tax Cuts and Jobs Act; Senate and House Committee Tax Reform Proposals;
P.L. 111-148, Patient Protection and Affordable Care Act; Repeal and Replace Proposals for Public Law 111-148, The Patient Protection and Affordable Care Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; H.R. 2077, Restoring the Patient's Voice Act of 2017; S. 469, H.R. 1245, Affordable and Safe Prescription Drug Importation Act; H.R. 1316, Prescription Drug Price Transparency Act; S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; S. 1348, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017; S. 1369, H.R. 2974, Stop Price Gouging Act of 2017; S. 1681, A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services; H.R. 849, the Protecting Seniors Access to Medicare Act; Proposals related to drug pricing; S. 892, Opioid Addiction Prevention Act of 2017; S. 1827, H.R. 3922, Keeping Kids' Insurance Dependable and Secure Act; Proposals to reauthorize the Biomedical Advanced Research and Development Authority;
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, Treasury, Dept of
S. Con. Res. 3, A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026; S. 1519, H.R. 2810, National Defense Authorization Act for Fiscal Year 2018; H.R.244, Consolidated Appropriations Act 2017 (P.L.115-31); FY2018, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations;
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, Treasury, Dept of
Senate and House Committee Tax Reform Proposals;
P.L. 111-148, Patient Protection and Affordable Care Act; Repeal and Replace Proposals for Public Law 111-148, The Patient Protection and Affordable Care Act; H.R. 1628, American Health Care Act of 2017; S. 934, H.R. 2430, FDA Reauthorization Act of 2017; Implementation/Reauthorization of The Prescription Drug User Fee Act (PDUFA); Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; S. 204, H.R. 878, Trickett Wendler Right to Try Act of 2017; H.R. 2077, Restoring the Patient's Voice Act of 2017; S. 469, H.R. 1245, Affordable and Safe Prescription Drug Importation Act; S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; Proposals related to drug pricing; Implementation of P.L.114-255, 21st Century Cures Act; Issues related to depression and mental health;
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of
S. Con. Res. 3, A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026; Other Labor, Health and Human Services Appropriations (no bills introduced);
Policies to enhance patient access to medicines in Medicare; Review of proposed rule regarding testing of Medicare part B prescription drug models; Proposals related to protected classes; Medicare payment proposals;
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
H.R. 6: 21st Century Cures/Innovation Act
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
S 959-The Pharmaceutical Compounding Quality and Accountability Act; HR 1919-The Safeguarding America's Pharmaceuticals Act of 2013
Filing targets: HOUSE OF REPRESENTATIVES, SENATE